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Table 2 Baseline clinical characteristics of the patients in the DANISH and ASIM studies*

From: Extracellular matrix turnover biomarkers reflect pharmacodynamic effects and treatment response of adalimumab in patients with axial spondyloarthritis—results from two randomized controlled trials

Demographic feature

DANISH

ASIM

DANISH vs ASIM

Total (N = 49)

Adalimumab (N = 24)

Placebo (N = 25)

Total (N = 45)

Adalimumab (N = 22)

Placebo (N = 23)

p-value

Age, years

39.5 (11.2)

40.9 (12.5)

38.2 (9.9)

37.6 (9.9)

39.8 (11.4)

35.4 (7.9)

0.47

Sex, male

38 (77.6%)

18 (75.0%)

20 (80.0%)

25 (55.6%)

13 (59.1%)

12 (52.2%)

0.02

HLA–B27 positive

43 (87.8%)

23 (95.8%)

20 (80.0%)

34 (75.6%)

16 (72.7%)

18 (78.3%)

0.12

Symptom duration, years

10.9 (8.2)

12.1 (7.1)

9.9 (9.1)

12.4 (11.2)

14.5 (14.1)

10.3 (7.3)

0.98

ASDAS

3.2 (0.8)

3.3 (0.8)

3.2 (0.8)

3.5 (0.8)

3.6 (0.7)

3.5 (0.9)

0.1

BASDAI

6 (1.7)

6 (1.4)

6.1 (1.9)

6.4 (1.4)

6.3 (1.2)

6.4 (1.6)

 < 0.01

BASFI

4.6 (1.9)

4.8 (1.7)

4.3 (2.1)

5.1 (2.1)

5.2 (2.0)

5.0 (2.2)

0.22

BASMI

3.3 (2.0)

3.3 (2.0)

3.3 (2.1)

2.7 (2.0)

2.6 (2.0)

2.7 (2.0)

0.13

Fulfillment of the modNY criteria

46 (93.9%)

24 (100.0%)

22 (88.0%)

27 (60.0%)

13 (59.1%)

14 (60.9%)

 < 0.01

SPARCC inflammation score

8.2 (10.4)

5.0 (6.6)

11.2 (12.5)

7.4 (8.5)

5.8 (5.9)

9.1 (10.4)

0.74

SPARCC SSS fat score

15.6 (15.4)

18.7 (16.5)

12.6 (13.9)

6.4 (8.0)

6.4 (7.5)

6.4 (8.7)

 < 0.01

SPARCC SSS erosion score

2.5 (4.1)

1.3 (2.1)

3.7 (5.2)

3.0 (3.2)

2.4 (2.7)

3.5 (3.7)

0.24

SPARCC SSS backfill score

5.7 (5.6)

6.5 (6.4)

4.9 (4.7)

0.8 (1.7)

0.9 (1.9)

0.8 (1.4)

 < 0.01

SPARCC spine inflammation score

13.6 (16.5)

15.9 (19.0)

11.4 (13.8)

8.2 (11.3)

9.5 (12.6)

6.8 (10.1)

0.11

CanDen spine inflammation score

16.0 (21.2)

15.6 (15.1)

16.3 (26.0)

6.7 (9.0)

8.1 (10.4)

5.3 (7.5)

0.01

CanDen spine erosion score

0.1 (0.5)

0.2 (0.7)

0.0 (0.2)

0.5 (0.9)

0.4 (0.7)

0.6 (1.0)

 < 0.01

CanDen Spine fat score

19.1 (24.7)

28.6 (31.2)

10.1 (10.7)

5.2 (9.2)

7.8 (11.9)

2.7 (4.8)

 < 0.01

CanDen Spine new bone formation score​

12.8 (33.0)

21.6 (45.1)

4.4 (8.7)

10.4 (22.5)

13.2 (28.1)

7.8 (15.7)

0.61

mSASSS

8.6 (13.2)

11.1 (15.9)

6.1 (9.5)

7.8 (14.0)

9.1 (15.5)

6.5 (12.6)

0.72

C1M, ng/mL

103.2 (78.4)

109.9 (73.1)

96.8 (84.2)

77.8 (76.6)

81.1 (61.6)

74.6 (90.0)

0.02

C3M, ng/mL

13.9 (3.0)

14.2 (3.1)

13.7 (3.1)

13.4 (2.6)

13.7 (2.5)

13.1 (2.6)

0.51

C4M, ng/mL

33.6 (8.6)

33.7 (9.4)

33.5 (7.8)

32.4 (7.4)

33.6 (7.2)

31.3 (7.6)

0.64

C6M, ng/mL

22.7 (7.8)

22.9 (7.1)

22.5 (8.6)

21.3 (6.6)

22.3 (7.1)

20.4 (6.0)

0.37

CRP, mg/L

16.6 (23.5)

16.9 (18.4)

16.2 (28.0)

10.3 (14.6)

11.3 (12.3)

9.3 (16.7)

0.02

CRPM, ng/mL

11.8 (4.1)

11.5 (2.8)

12.1 (5.1)

13.8 (14.9)

15.4 (20.7)

12.2 (5.3)

0.67

PROM, ng/mL

0.2 (0.1)

0.2 (0.1)

0.2 (0.1)

0.2 (0.1)

0.2 (0.1)

0.2 (0.1)

0.6

VICM, ng/mL

6.8 (5.3)

7.6 (6.1)

6.1 (4.5)

3.6 (2.7)

4.4 (3.3)

2.9 (1.8)

 < 0.01

CPa9-HNE, ng/mL

80.9 (33.5)

87.0 (36.5)

75.1 (29.9)

128.3 (61.4)

135.0 (57.3)

121.9 (65.7)

 < 0.01

C2M, ng/mL

20.3 (3.4)

20.3 (2.6)

20.4 (4.1)

21.7 (5.3)

21.8 (4.9)

21.6 (5.8)

0.28

T2CM, ng/mL

6.3 (2.1)

6.2 (1.8)

6.4 (2.4)

5.4 (1.0)

5.4 (0.9)

5.4 (1.1)

 < 0.01

C10C, ng/mL

2634.9 (555.2)

2755.6 (462.6)

2519.0 (618.8)

2585.0 (655.6)

2655.3 (811.9)

2517.8 (470.0)

0.37

PRO-C3, ng/mL

11.0 (2.1)

10.9 (2.0)

11.1 (2.2)

10.5 (2.8)

10.3 (2.1)

10.6 (3.3)

0.08

PRO-C4, ng/mL

7026.4 (832.7)

6998.8 (501.6)

7052.9 (1069.6)

6592.2 (775.7)

6552.8 (822.0)

6629.9 (745.2)

0.04

PRO-C6, ng/mL

8.2 (2.6)

7.9 (2.4)

8.5 (2.9)

7.4 (1.7)

7.5 (1.9)

7.4 (1.6)

0.31

PRO-C2 ng/mL

21.9 (8.4)

22.3 (9.6)

21.6 (7.2)

18.7 (14.3)

16.6 (13.0)

20.8 (15.4)

 < 0.01

  1. *Except where indicated otherwise, mean ± SD is presented. Study differences were analyzed by Mann-Whitney tests or chi-square test, as appropriate. Abbreviations: ASDAS Assess Disease Activity in Ankylosing Spondylitis, BASDAI Bath Ankylosing Spondylitis Disease Activity Index (scale 0–10), BASFI Bath Ankylosing Spondylitis Functional Index (scale 0–10), BASMI Bath Ankylosing Spondylitis Metrology Index (scale 0–10), modNY criteria Modified New York Criteria, SPARCC Spondyloarthritis Research Consortium of Canada, SSS SI joint structural lesion score, CanDen Canada and Denmark, mSASSS Modified Stoke Ankylosing Spondylitis Score (scale 0–40), C1M metalloproteinase (MMP)-2/9/13-degraded type I collagen, C3M MMP-degraded type III collagen, C4M MMP (multiple)-degraded type IV collagen, C6M MMP-2/9-degraded type VI collagen, CRP C-reactive protein, CRPM CRP metabolite, PROM MMP-1 and MMP-13-mediated degradation of prolargin, VICM citrullinated and MMP-degraded vimentin, CPa9-HNE human elastase (HNE)-mediated degradation of calprotectin, C2M MMP (multiple)-degraded type II collagen, T2CM MMP-1/13-mediated degradation of type II collagen, C10C cathepsin-K-mediated degradation of type X collagen PRO-C3 pro-peptide of type III collagen, PRO-C4 type IV 7S domain collagen, PRO-C6 type VI alpha-3 chain collagen, PRO-C2 pro-peptide of type II collagen
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Arthritis Research & Therapy

ISSN: 1478-6362

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